Public health in the United States is characterized by highly prevalent chronic disease conditions. More than 90 million Americans live with chronic illnesses which result in 70% of the deaths in the United States each year. The medical care costs of people with chronic diseases account for more than 75% of the nation's $1.4 trillion medical care costs. Many of these conditions are linked to systemic stress and production of free radicals, reduced antioxidant defense, and attenuated nitric oxide synthase (NOS) activity.
Free radicals (oxidation) are highly charged molecules with open negative charges which are involved with cell and tissue damaging biochemical reactions. Of particular interest are lipid peroxidation reactions resulting in an increase in LDL cholesterol as well as a reduction of the compliance of the arterial walls by increased cross-linking between cells. Previous work by Niki et al. has shown that various antioxidants with different functions inhibit lipid peroxidation and the deleterious effects caused by the lipid peroxidation products. (Niki E, Yoshida Y, Saito Y et al. “Lipid peroxidation: mechanisms, inhibition, and biological effects.” Biochem Biophys Res Commun. 2005 Dec. 9; 338(1):668-76.) Work performed by Leonard et al. demonstrated in laboratory procedures that black cumin oil has strong free radical quenching activity and has significant inhibitory effect on LDL oxidation. (Leonard, A S, Saltzman, D A, Mueller, M: Creation of Super-Potent Antioxidant Values Through Synergy of Cold-Pressed Botanic Oils for Therapeutic Purposes. Naturopathy Digest Vol 1, No 7, July 2006.) [hereinafter “Leonard”]
The biological roles of lipid peroxidation products have recently received a great deal of attention, but its clinical significance must be demonstrated in future studies. Animal studies on antioxidants have demonstrated that treatment initiated to reduce oxidative stress prevents the age-associated development of high blood pressure in genetically hypertensive rats. (Nabha L, Garbem J C, Buller C L et al. “Vascular oxidative stress precedes high blood pressure in spontaneously hypertensive rats.” Clin Exp Hypertens. 2005 January; 27(1):71-82.)
Clinical trials with humans focusing on antioxidants and cardiovascular disease have in the past been unsuccessful due to the dose-dependent effects of antioxidants, for example studies on vitamin E. However, in animal trials, a correlation was found between dosage of antioxidant consumption and the effect of reduction of cholesterol for hyperlipidemic mice and rabbits. (Weinberg P D et al. “Analysis of the variable effect of dietary vitamin E supplements on experimental atherosclerosis.” J Plant Physio. 2005 July; 162(7): 823-33.)
The antioxidant supplement Immuno-Viva™, investigated in human subjects in this patent application is a pure blend of black raspberry and black cumin seed oils using a proprietary Nature FRESH-Cold Press™ processing technology. The Immune Lift™ antioxidant supplement is a blend of de-fatted black cumin seed flour and de-fatted black raspberry seed flour. Both products are manufactured by Botanic Oil Innovations, Inc., Spooner, Wis. The proprietary process is carried out in an oxygen deprived nitrogen/carbon dioxide atmosphere which optimizes nutrient yield. The process does not involve solvents, bleaching agents or high temperatures. The products contain high levels of alpha, gamma and beta tocopherols, as well as in gamma tocotrienols. Main components of the products are—saturated, mono-unsaturated, poly-unsaturated fatty acids and carbohydrate. The omega 3:6 ratio equals 2:5. (Leonard)
Preliminary animal studies have evaluated the effects of black raspberry seed oil (Botanic Oil Innovations, Inc.) on splenic lymphocyte populations in mice. The study showed that mice fed standard meals with 10% oil added showed significantly elevated levels of natural killer cells (NK) and cytotoxic T lymphocyte cells (CD 8). Both NK and CD 8 are believed to enable the body to better fight the damage caused by free radicals and to enhance the body's ability to fight disease and cancer. (Leonard)
Further preliminary pilot tests have evaluated a possible synergistic effect of Immuno-Viva™ oil and an attenuated Salmonella Typhimurium that synthesizes interleukin 2 (IL-2). It was shown that the IL-2 reduced hepatic metastases by 58% in mice, and an additional 30% reduction in metastases was found including the oil. (Saltzman D A, Leonard A S: Studies of the Immune Enhancement and Anti-Tumor Properties of Highly Potent Antioxidant Oils in Conjunction with Attenuated Salmonella Typhimurium Containing the Gene for Interleukin-2. University of Minnesota. 2006).